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[ad_1] A person receives a COVID-19 vaccination dose, during a free distribution of COVID-19 rapid test kits for those who received vaccination shots or booster shots, at Union Station on January 7, 2022 in Los Angeles, California. Mario Tama | Getty Images The U.S. Food and Drug Administration 's independent panel of advisors raised doubts about the need to "periodically" update Covid vaccines, noting that it's unclear if the virus is seasonal like the flu. Advisors on Thursday unanimously voted that new jabs for the fall should be monovalent — meaning they are designed against one variant of Covid — and target one of the omicron XBB strains . Those are now the dominant variants nationwide.  But the original voting question included language about whether the panel recommends a "periodic update" to Covid shots.  Dr. Peter Marks, head of the FDA's vaccine division, asked the panel's chair to strike the wording from the question after severa...

[ad_1] Juul packages are seen on a shelf at Empire Smoke Shop on December 07, 2022 in the Flatbush neighborhood of Brooklyn borough in New York City.  Michael M. Santiago | Getty Images The Food and Drug Administration  announced  Thursday that it has reversed its ban on Juul e-cigarettes while it reviews new court decisions and considers updated information provided by the vape-maker. The FDA first stopped the company from marketing its products in 2022, but they have stayed on shelves pending an appeal. Juul has maintained its status as the No. 2 e-cigarette maker in the U.S. during this time. Now, the FDA says Juul's products are back under agency review — although it emphasized that this new status was not an indication they would be fully cleared. It said federal statutes barred it from disclosing additional information. In a statement, Juul said it appreciated the FDA's decision, adding it now looks forward to "re-engaging with the agency on a science- and evide...

[ad_1] A messy legal fight over the Food and Drug Administration's approval of the abortion pill mifepristone poses risks to the biopharma industry that go beyond the single drug. If a subsequent decision tosses out the pill's approval, it could potentially stifle innovation in the sector and deter investments in the development of life-changing drugs, biopharma companies and experts in law and economics say.  related investing news The ruling Friday by U.S. District Judge Matthew Kacsmaryk of Amarillo, Texas, appears to be the first time a court has suspended the FDA's approval of a medication. The 5th U.S. Circuit Court of Appeals late Wednesday partly granted the Biden administration's request to put the order on hold, making mifepristone available for now but with significant restrictions .  The Justice Department will seek emergency intervention from the U.S. Supreme Court, it said Thursday. Nationwide access to mifepristone still hangs in the balance as the...

[ad_1] FDA gives full approval to a drug designed to slow Alzheimer's disease - CBS News Watch CBS News The Food and Drug Administration on Thursday gave its approval to Leqembi, a drug designed to slow the progression of Alzheimer's disease. Leqembi is not considered a cure for Alzheimer’s, but will be covered by Medicare. Dr. Jon LaPook has more. Be the first to know Get browser notifications for breaking news, live events, and exclusive reporting. Not Now Turn On [ad_2] Source link https://worldnews2023.com/health/fda-gives-full-approval-to-a-drug-designed-to-slow-alzheimers-disease/?feed_id=309338&_unique_id=668b8fdb27ad1

[ad_1] A GSK lab in London. Oli Scarff | Getty Images The Food and Drug Administration on Wednesday approved an RSV vaccine produced by GlaxoSmithKline for use on adults ages 60 and older. The approval, the first ever globally by a regulatory body for an RSV vaccine , is a decisive victory for GSK in a race against drugmakers Pfizer and Moderna to bring to market a shot that targets the respiratory syncytial virus . Shares of GSK rose nearly 2% Wednesday following the approval. GSK's chief scientific officer Tony Wood said in a statement the decision "marks a turning point" in the company's effort to reduce the "significant burden" of RSV. The company will now focus on ensuring eligible older adults in the U.S. can access the vaccine "as quickly as possible," he said. GSK will also work toward regulatory review and approval of the shot in other countries. London-based GSK during an earnings presentation last week said it has "mil...

[ad_1] Syringe with Covid-19 vaccine against the XBB Variant. Fight against virus Covid-19 Coronavirus, Vaccination and immunization. Undefined Undefined | Istock | Getty Images U.S. Food and Drug Administration staff on Monday said updated Covid boosters should target XBB omicron subvariants for the upcoming fall and winter vaccination campaign.  The U.S. should use a monovalent vaccine targeting either XBB.1.5, XBB.1.16, or XBB.2.3, collectively the dominant strains nationwide, the staff said in a briefing document .  related investing news The FDA staff made the conclusion ahead of a meeting on Thursday, when a panel of external advisors to the agency will recommend a strain for new Covid shots to target later this year. There is no set date for when the vaccination campaign will begin. Vaccine manufacturers will be expected to update their shots once that strain is selected. Pfizer , Moderna and Novavax are already developing versions of their respective vaccines targeti...

[ad_1] A vial labelled "Novavax V COVID-19 Vaccine" is seen in this illustration taken January 16, 2022.  Dado Ruvic | Reuters Novavax 's updated Covid vaccine won the backing of U.S. regulators on Tuesday, putting the shot on track to roll out weeks after new jabs from Pfizer and Moderna reached Americans. The Food and Drug Administration authorized Novavax's single-strain vaccine, which targets omicron subvariant XBB.1.5 , for emergency use in people ages 12 and up. The Centers for Disease Control and Prevention is now including Novavax's shot in the same recommendation it issued last month for updated vaccines from Pfizer and Moderna. That recommendation says all Americans ages six months and older can receive an updated Covid jab. Novavax said in a statement that doses of the shot will likely be available within the next few days. "Novavax's authorization today means people will now have the choice of a protein-based non-MRNA option to help...

[ad_1] Kratom products continue to draw criticism from health experts - CBS News Watch CBS News The Food and Drug Administration says the controversial herbal supplement kratom "exposes users to the risks of addiction, abuse, and dependence." Mark Strassman reports. Be the first to know Get browser notifications for breaking news, live events, and exclusive reporting. Not Now Turn On [ad_2] Source link https://worldnews2023.com/health/kratom-products-continue-to-draw-criticism-from-health-experts/?feed_id=251673&_unique_id=65b6192cda6b2